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Only for medical professionals to read about the safety of biological agents in the treatment of IBD, come to understand quickly! Inflammatory bowel disease (IBD) persists and recurs.
Due to the need for long-term treatment and the increased risk of opportunistic infections in patients with IBD, safety issues in treatment are particularly important.
As the most powerful weapon in the treatment of IBD, the safety of biological agents is obviously also concerned! We have discussed a similar topic earlier (the treatment of inflammatory bowel disease has a long way to go, and this drug has been proven to be safe and effective for long-term use).
Recently, the safety data of intestinal selective biologics has been released again.
We are here to send a meal of original "snack"-three groups of vedelizumab safety data express, for your reference in IBD diagnosis and treatment .
EVOLVE Study: Treatment Outcomes of Verdrizumab in Patients with Inflammatory Bowel Disease Without Biological Treatment in the Real World (IF: 8.
658, Journal: J Crohns Colitis, 2021) Original link: https://pubmed.
ncbi .
nlm.
nih.
gov/33786600/Background and purpose: To compare the α4β7 integrin inhibitor veldrizumab and anti-tumor necrosis factor-α (TNF-α) drugs in ulcerative colons that have not been treated with biological agents Real-world clinical effectiveness and safety in inflammatory disease (UC) and Crohn’s disease (CD) [1].
Methods: This is a retrospective study of adult UC/CD patients in Canada, Greece, and the United States receiving vedelizumab or anti-TNF-α therapy.
The main results are clinical effectiveness (clinical response, clinical remission, mucosal healing), serious adverse events (SAE) and the incidence of severe infections (SI).
Secondary results include the cumulative rate of continuous treatment, increased dose, and so on.
Use inverse probability weighting for adjusted analysis.
Results: A total of 1095 patients (604 UC, 491 CD) were enrolled.
By 24 months, the clinical effectiveness of the two groups was similar.
The incidence of SAEs [HR=0.
42 (0.
28-0.
62)] and SIs [HR=0.
40 (0.
19-0.
85)] of vedelizumab was significantly lower than that of patients with anti-TNF-α.
The unadjusted results in the UC population showed that, overall, 6.
8% and 19.
2% of SAEs occurred in the vedelizumab group and the anti-TNF-α group, respectively.
The adjusted results found that compared with anti-TNF-α, patients with vedelizumab had fewer SAEs [HR=0.
37 (0.
21-0.
63)], and there was no difference between the two groups in SIs [HR=0.
56 (0.
21-1.
51) ](figure 1).
Figure 1: The safety risk of vedelizumab and anti-TNF-α groups in UC The unadjusted results show that the overall proportion of SAEs in the vedelizumab and anti-TNF-α groups in the CD population They were 8.
3% and 19.
0%, respectively.
The adjusted results showed that compared with anti-TNF-α, there were fewer SAEs [HR=0.
49 (0.
28-0.
86)] and SIs [HR=0.
26 (0.
08-0.
87)] in the vedelizumab group (Figure 2) .
Figure 2: The safety risk of vedelizumab and anti-TNF-α group in CD compared with the 24-month treatment duration rate of vedelizumab group in UC patients compared with the anti-TNF-α group (p<0.
01 )higher.
In UC patients, the incidence of disease exacerbation in the vedelizumab group was lower than that in the anti-TNF-α group [HR=0.
58 (0.
45-0.
76)].
There were no significant differences in other results between the two groups.
Conclusion: In the real world, the first-line biological treatment of UC and CD patients who have not been treated with biological agents shows that veclizumab and anti-TNF-α therapy are equally effective in controlling disease symptoms, but veclizumab Has better security.
In patients with ulcerative colitis, the risk of severe infection with veldrizumab is lower than that of anti-TNF-α (IF: 8.
549, Journal: Clin Gastroenterol Hepatol, 2021) Original link: https://pubmed.
ncbi.
nlm .
nih.
gov/33640480/ Background and purpose: A retrospective cohort study comparing the risk of serious infections in patients with IBD treated with anti-TNF-α and vedelizumab [2].
Methods: The medical insurance database was used to enroll IBD patients who were first treated with anti-TNF-α or vedelizumab during the period 2014-2018.
The Cox proportional hazards model was used to compare the risk of serious infections (infections requiring hospitalization) between patients treated with veldrizumab or anti-TNF-α.
Results: 4881 patients treated with anti-TNF-α (60% were CD) were enrolled, of which 434 patients developed severe infections during 5786 person-years of follow-up, and 1106 patients treated with velizumab (39%) Is CD), 86 of which developed serious infections during the 1040 person-year follow-up.
In patients with UC, compared with anti-TNF-α, vedelizumab can reduce the risk of serious infection by 46% [hazard ratio (HR)=0.
54; 95% CI 0.
35-0.
83], but not in CD patients Significant differences were observed (HR=1.
30; 95%CI 0.
80-2.
11) (Figure 3).
Figure 3: Verdrizumab vs.
anti-TNF-α serious infection risk Conclusion: In an observational study of IBD patients, compared with anti-TNF-α, vedrilizumab was found in UC patients Medium is associated with a lower risk of serious infection.
VICOTRY Study: Comparison of the safety and effectiveness of veldrizumab and anti-TNF-α in the treatment of Crohn's disease (IF 7.
515, Journal: Aliment Pharmacol Ther, 2020) Original link: https://pubmed.
ncbi.
nlm .
nih.
gov/32656800/ Background: In the treatment of CD, there is no direct comparison between vedelizumab and anti-TNF-α [3]. Objective: To compare the safety and effectiveness of vedelizumab and anti-TNF-α in the treatment of adult CD.
Methods: In a retrospective observational cohort study (May 2014-December 2017), vedelizumab and anti-TNF-α (infliximab, adalimumab, ertuzumab) were treated CD propensity score weighted comparison.
The main result is the relative risk of infection or non-infectious serious adverse events (including the need for antibiotics, antiviral drugs, antifungal drugs, hospitalization or discontinuation of treatment, or death).
The secondary comparative efficacy results were clinical remission (remission of CD-related symptoms), clinical remission without hormones, and endoscopic remission (no ulcer/erosion).
Results: We included 1266 patients (n=659 in the vedelizumab group).
Compared with anti-TNF-α therapy, the incidence of non-infectious serious adverse events (OR 0.
072, 95% CI: 0.
012-0.
242) of vedelizumab was significantly reduced, but there was no difference in the incidence of serious infections ( OR 1.
183, 95% CI: 0.
786-1.
795).
After adjusting for the difference in exposure time, the incidence of non-infectious serious adverse events of vedelizumab was still significantly lower than that of anti-TNF-α (OR 0.
940, 95% CI 0.
892-0.
984).
Verdrizumab and anti-TNF-α treatment achieved clinical remission (HR 0.
932, 95% CI 0.
707-1.
228), hormone-free clinical remission (HR 1.
250, 95% CI 0.
677-2.
310) or endoscopic remission (HR 0.
827) , 95% CI 0.
595-1.
151) there was no significant difference.
CONCLUSION: The risk of non-infectious serious adverse events in the treatment of vedelizumab for CD is significantly lower than that of anti-TNF-α, but there is no significant difference in severe infection; there is no significant difference between the two in terms of disease remission.
Summary The above is a relatively new research in the field of IBD biologics and published in higher IF journals.
From these data and conclusions, we can see that compared with anti-TNF-α, vedelizumab has better safety characteristics.
As we have always understood, intestinal-selective biologics are safer than system-selective biologics due to their unique targets.
The significant safety advantages of vedelizumab provide enlightenment for the application and selection of clinical biologics! References: [1]Bressler B, Yarur A, Silverberg MS, Bassel M, Bellaguarda E, Fourment C, Gatopoulou A, Karatzas P, Kopylov U, Michalopoulos G, Michopoulos S, Navaneethan U, Rubin DT, Siffledeen J, Singh A , Soufleris K, Stein D, Demuth D, Mantzaris GJ.
Vedolizumab and Anti-TNFα Real-World Outcomes in Biologic-Naïve Inflammatory Bowel Disease Patients: Results from the EVOLVE Study.
J Crohns Colitis.
2021 Mar 31:jjab058.
doi: 10.
1093 /ecco-jcc/jjab058.
Epub ahead of print.
PMID: 33786600.
[2]Singh S, Heien HC, Herrin J, Dulai PS, Sangaralingham L, Shah ND, Sandborn WJ.
Comparative Risk of Serious Infections with Tumor Necrosis Factor- α Antagonists vs.
Vedolizumab in Patients with Inflammatory Bowel Diseases.
Clin Gastroenterol Hepatol.
2021 Feb 25:S1542-3565(21)00210-X.
doi: 10.
1016/j.
cgh.
2021.
02.
032.
Epub ahead of print.
Due to the need for long-term treatment and the increased risk of opportunistic infections in patients with IBD, safety issues in treatment are particularly important.
As the most powerful weapon in the treatment of IBD, the safety of biological agents is obviously also concerned! We have discussed a similar topic earlier (the treatment of inflammatory bowel disease has a long way to go, and this drug has been proven to be safe and effective for long-term use).
Recently, the safety data of intestinal selective biologics has been released again.
We are here to send a meal of original "snack"-three groups of vedelizumab safety data express, for your reference in IBD diagnosis and treatment .
EVOLVE Study: Treatment Outcomes of Verdrizumab in Patients with Inflammatory Bowel Disease Without Biological Treatment in the Real World (IF: 8.
658, Journal: J Crohns Colitis, 2021) Original link: https://pubmed.
ncbi .
nlm.
nih.
gov/33786600/Background and purpose: To compare the α4β7 integrin inhibitor veldrizumab and anti-tumor necrosis factor-α (TNF-α) drugs in ulcerative colons that have not been treated with biological agents Real-world clinical effectiveness and safety in inflammatory disease (UC) and Crohn’s disease (CD) [1].
Methods: This is a retrospective study of adult UC/CD patients in Canada, Greece, and the United States receiving vedelizumab or anti-TNF-α therapy.
The main results are clinical effectiveness (clinical response, clinical remission, mucosal healing), serious adverse events (SAE) and the incidence of severe infections (SI).
Secondary results include the cumulative rate of continuous treatment, increased dose, and so on.
Use inverse probability weighting for adjusted analysis.
Results: A total of 1095 patients (604 UC, 491 CD) were enrolled.
By 24 months, the clinical effectiveness of the two groups was similar.
The incidence of SAEs [HR=0.
42 (0.
28-0.
62)] and SIs [HR=0.
40 (0.
19-0.
85)] of vedelizumab was significantly lower than that of patients with anti-TNF-α.
The unadjusted results in the UC population showed that, overall, 6.
8% and 19.
2% of SAEs occurred in the vedelizumab group and the anti-TNF-α group, respectively.
The adjusted results found that compared with anti-TNF-α, patients with vedelizumab had fewer SAEs [HR=0.
37 (0.
21-0.
63)], and there was no difference between the two groups in SIs [HR=0.
56 (0.
21-1.
51) ](figure 1).
Figure 1: The safety risk of vedelizumab and anti-TNF-α groups in UC The unadjusted results show that the overall proportion of SAEs in the vedelizumab and anti-TNF-α groups in the CD population They were 8.
3% and 19.
0%, respectively.
The adjusted results showed that compared with anti-TNF-α, there were fewer SAEs [HR=0.
49 (0.
28-0.
86)] and SIs [HR=0.
26 (0.
08-0.
87)] in the vedelizumab group (Figure 2) .
Figure 2: The safety risk of vedelizumab and anti-TNF-α group in CD compared with the 24-month treatment duration rate of vedelizumab group in UC patients compared with the anti-TNF-α group (p<0.
01 )higher.
In UC patients, the incidence of disease exacerbation in the vedelizumab group was lower than that in the anti-TNF-α group [HR=0.
58 (0.
45-0.
76)].
There were no significant differences in other results between the two groups.
Conclusion: In the real world, the first-line biological treatment of UC and CD patients who have not been treated with biological agents shows that veclizumab and anti-TNF-α therapy are equally effective in controlling disease symptoms, but veclizumab Has better security.
In patients with ulcerative colitis, the risk of severe infection with veldrizumab is lower than that of anti-TNF-α (IF: 8.
549, Journal: Clin Gastroenterol Hepatol, 2021) Original link: https://pubmed.
ncbi.
nlm .
nih.
gov/33640480/ Background and purpose: A retrospective cohort study comparing the risk of serious infections in patients with IBD treated with anti-TNF-α and vedelizumab [2].
Methods: The medical insurance database was used to enroll IBD patients who were first treated with anti-TNF-α or vedelizumab during the period 2014-2018.
The Cox proportional hazards model was used to compare the risk of serious infections (infections requiring hospitalization) between patients treated with veldrizumab or anti-TNF-α.
Results: 4881 patients treated with anti-TNF-α (60% were CD) were enrolled, of which 434 patients developed severe infections during 5786 person-years of follow-up, and 1106 patients treated with velizumab (39%) Is CD), 86 of which developed serious infections during the 1040 person-year follow-up.
In patients with UC, compared with anti-TNF-α, vedelizumab can reduce the risk of serious infection by 46% [hazard ratio (HR)=0.
54; 95% CI 0.
35-0.
83], but not in CD patients Significant differences were observed (HR=1.
30; 95%CI 0.
80-2.
11) (Figure 3).
Figure 3: Verdrizumab vs.
anti-TNF-α serious infection risk Conclusion: In an observational study of IBD patients, compared with anti-TNF-α, vedrilizumab was found in UC patients Medium is associated with a lower risk of serious infection.
VICOTRY Study: Comparison of the safety and effectiveness of veldrizumab and anti-TNF-α in the treatment of Crohn's disease (IF 7.
515, Journal: Aliment Pharmacol Ther, 2020) Original link: https://pubmed.
ncbi.
nlm .
nih.
gov/32656800/ Background: In the treatment of CD, there is no direct comparison between vedelizumab and anti-TNF-α [3]. Objective: To compare the safety and effectiveness of vedelizumab and anti-TNF-α in the treatment of adult CD.
Methods: In a retrospective observational cohort study (May 2014-December 2017), vedelizumab and anti-TNF-α (infliximab, adalimumab, ertuzumab) were treated CD propensity score weighted comparison.
The main result is the relative risk of infection or non-infectious serious adverse events (including the need for antibiotics, antiviral drugs, antifungal drugs, hospitalization or discontinuation of treatment, or death).
The secondary comparative efficacy results were clinical remission (remission of CD-related symptoms), clinical remission without hormones, and endoscopic remission (no ulcer/erosion).
Results: We included 1266 patients (n=659 in the vedelizumab group).
Compared with anti-TNF-α therapy, the incidence of non-infectious serious adverse events (OR 0.
072, 95% CI: 0.
012-0.
242) of vedelizumab was significantly reduced, but there was no difference in the incidence of serious infections ( OR 1.
183, 95% CI: 0.
786-1.
795).
After adjusting for the difference in exposure time, the incidence of non-infectious serious adverse events of vedelizumab was still significantly lower than that of anti-TNF-α (OR 0.
940, 95% CI 0.
892-0.
984).
Verdrizumab and anti-TNF-α treatment achieved clinical remission (HR 0.
932, 95% CI 0.
707-1.
228), hormone-free clinical remission (HR 1.
250, 95% CI 0.
677-2.
310) or endoscopic remission (HR 0.
827) , 95% CI 0.
595-1.
151) there was no significant difference.
CONCLUSION: The risk of non-infectious serious adverse events in the treatment of vedelizumab for CD is significantly lower than that of anti-TNF-α, but there is no significant difference in severe infection; there is no significant difference between the two in terms of disease remission.
Summary The above is a relatively new research in the field of IBD biologics and published in higher IF journals.
From these data and conclusions, we can see that compared with anti-TNF-α, vedelizumab has better safety characteristics.
As we have always understood, intestinal-selective biologics are safer than system-selective biologics due to their unique targets.
The significant safety advantages of vedelizumab provide enlightenment for the application and selection of clinical biologics! References: [1]Bressler B, Yarur A, Silverberg MS, Bassel M, Bellaguarda E, Fourment C, Gatopoulou A, Karatzas P, Kopylov U, Michalopoulos G, Michopoulos S, Navaneethan U, Rubin DT, Siffledeen J, Singh A , Soufleris K, Stein D, Demuth D, Mantzaris GJ.
Vedolizumab and Anti-TNFα Real-World Outcomes in Biologic-Naïve Inflammatory Bowel Disease Patients: Results from the EVOLVE Study.
J Crohns Colitis.
2021 Mar 31:jjab058.
doi: 10.
1093 /ecco-jcc/jjab058.
Epub ahead of print.
PMID: 33786600.
[2]Singh S, Heien HC, Herrin J, Dulai PS, Sangaralingham L, Shah ND, Sandborn WJ.
Comparative Risk of Serious Infections with Tumor Necrosis Factor- α Antagonists vs.
Vedolizumab in Patients with Inflammatory Bowel Diseases.
Clin Gastroenterol Hepatol.
2021 Feb 25:S1542-3565(21)00210-X.
doi: 10.
1016/j.
cgh.
2021.
02.
032.
Epub ahead of print.
